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    Chemistry

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    Also known as: 34552-83-5, Loperamide hcl, Imodium, Suprasec, Loperamide (hydrochloride), Fortasec
    Molecular Formula
    C29H34Cl2N2O2
    Molecular Weight
    513.5  g/mol
    InChI Key
    PGYPOBZJRVSMDS-UHFFFAOYSA-N
    FDA UNII
    77TI35393C
    Loperamide Hydrochloride
    One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
    1 2D Structure

    Loperamide Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C29H33ClN2O2.ClH/c1-31(2)27(33)29(24-9-5-3-6-10-24,25-11-7-4-8-12-25)19-22-32-20-17-28(34,18-21-32)23-13-15-26(30)16-14-23;/h3-16,34H,17-22H2,1-2H3;1H
    2.1.3 InChI Key
    PGYPOBZJRVSMDS-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)C(=O)C(CCN1CCC(CC1)(C2=CC=C(C=C2)Cl)O)(C3=CC=CC=C3)C4=CC=CC=C4.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    77TI35393C
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Hydrochloride, Loperamide

    2. Imodium

    3. Loperamide

    4. Loperamide Monohydrochloride

    5. Monohydrochloride, Loperamide

    6. R 18553

    7. R-18553

    8. R18553

    2.3.2 Depositor-Supplied Synonyms

    1. 34552-83-5

    2. Loperamide Hcl

    3. Imodium

    4. Suprasec

    5. Loperamide (hydrochloride)

    6. Fortasec

    7. Imodium A-d

    8. 4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

    9. Nsc-696356

    10. Maalox Anti-diarrheal

    11. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

    12. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide;hydrochloride

    13. Mls000069779

    14. Chebi:6533

    15. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Hydrochloride

    16. R 18,553

    17. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidine Butyramide Hcl

    18. 77ti35393c

    19. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenylpiperidine-1-butyramide Monohydrochloride

    20. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutyramide Monohydrochloride

    21. Dissenten

    22. Lopemid

    23. Lopemin

    24. Loperyl

    25. Smr000058466

    26. Imosec

    27. Tebloc

    28. R-18553

    29. Maalox Antidiarrheal

    30. Blox

    31. Brek

    32. Diamode

    33. Loseramin

    34. Imotil

    35. Anti-diarrheal

    36. Kao-paverin

    37. Diar-aid

    38. Kaopectate 1-d

    39. K-pek Ii

    40. Pepto Diarrhea Control

    41. Imodium A-d Ez Chews

    42. Pj185

    43. Sr-01000075507

    44. Up And Up Anti Diarrheal

    45. Einecs 252-082-4

    46. C29h33cln2o2.hcl

    47. Unii-77ti35393c

    48. Loperamide, Hcl

    49. R 18553

    50. Prestwick_302

    51. Imodium (tn)

    52. Mfcd00058581

    53. Cpd000058466

    54. Loperamide Hydrochloride [usan:usp:jan]

    55. Loperamidi Hydrochloridum

    56. Opera_id_1508

    57. 4-(4-(p-chlorophenyl)-4-hydroxy-1-piperidyl)-n,n-dimethyl-2,2-diphenylbutyramide Hcl

    58. Chembl1707

    59. Loperamidehydrochloride

    60. Schembl15048

    61. R-18553 (hydrochloride)

    62. Mls001148627

    63. Mls002222200

    64. Spectrum2300241

    65. Regid_for_cid_71420

    66. Loperamide Hydrochloride ,(s)

    67. Hy-b0418a

    68. Dtxsid00880006

    69. Hms1568m10

    70. Hms1922j18

    71. Pharmakon1600-02300241

    72. Bcp28441

    73. Loperamide Hydrochloride (jan/usp)

    74. Tox21_500708

    75. Ccg-39494

    76. Loperamide Hydrochloride [mi]

    77. Nsc696356

    78. Nsc759568

    79. S2480

    80. Loperamide Hydrochloride [jan]

    81. Akos015846351

    82. Ac-8242

    83. Adl 2-1294

    84. Loperamide Hydrochloride [usan]

    85. Lp00708

    86. Nc00572

    87. Nsc 759568

    88. Nsc-759568

    89. Loperamide Hydrochloride [mart.]

    90. Loperamide Hydrochloride [vandf]

    91. Loperamide Hydrochloride [usp-rs]

    92. Loperamide Hydrochloride [who-dd]

    93. Loperamide Hydrochloride [who-ip]

    94. Ncgc00094059-01

    95. Ncgc00094059-02

    96. Ncgc00094059-03

    97. Ncgc00094059-04

    98. Ncgc00094059-05

    99. Ncgc00180886-01

    100. Ncgc00180886-02

    101. Ncgc00261393-01

    102. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-, Monohydrochloride

    103. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Monohydrochloride

    104. 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

    105. As-13181

    106. Bl166178

    107. B1392

    108. Eu-0100708

    109. Ft-0627973

    110. L0154

    111. Sw196602-3

    112. Loperamide Hydrochloride [ep Impurity]

    113. Loperamide Hydrochloride [orange Book]

    114. D00729

    115. D78217

    116. L 4762

    117. Loperamide Hydrochloride [ep Monograph]

    118. Loperamide Hydrochloride [usp Monograph]

    119. Loperamidi Hydrochloridum [who-ip Latin]

    120. 552l835

    121. A822272

    122. Sr-01000075507-1

    123. Sr-01000075507-3

    124. Sr-01000075507-8

    125. W-106729

    126. Q27107231

    127. Loperamide Hydrochloride, Vetranal(tm), Analytical Standard

    128. Imodium Multi-symptom Relief Component Loperamide Hydrochloride

    129. Loperamide Hydrochloride Component Of Imodium Multi-symptom Relief

    130. Loperamide Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    131. Loperamide Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    132. 4-(4-chlorophenyl)-4-hydroxy-n,.alpha.-diphenyl-1-piperidinebutanamide Monohydrochloride

    133. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-?,?-diphenyl-1-piperidinebutanamide Hydrochloride

    134. Loperamide Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    135. Loperamide Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    136. 4-(4-chlorophenyl)-1-[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4-hydroxypiperidin-1-ium Chloride

    137. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamide Hydrochloride

    138. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamidehydrochloride

    139. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-1-piperidinebutyramide Monohydrochloride

    140. 4-[4-(4-chlorophenyl)-4-oxidanyl-piperidin-1-yl]-n,n-dimethyl-2,2-diphenyl-butanamide Hydrochloride

    141. Loperamide Hydrochloride For System Suitability, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 513.5 g/mol
    Molecular Formula C29H34Cl2N2O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count7
    Exact Mass512.1997337 g/mol
    Monoisotopic Mass512.1997337 g/mol
    Topological Polar Surface Area43.8 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity623
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameImodium
    Active IngredientLoperamide hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyMcneil Cons

    2 of 8  
    Drug NameImodium a-d ez chews
    Active IngredientLoperamide hydrochloride
    Dosage FormTablet, chewable
    RouteOral
    Strength2mg
    Market StatusOver the Counter
    CompanyMcneil

    3 of 8  
    Drug NameLoperamide hydrochloride
    PubMed HealthLoperamide (By mouth)
    Drug ClassesAntidiarrheal, Gastrointestinal Agent
    Drug LabelLoperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s...
    Active IngredientLoperamide hydrochloride
    Dosage FormTablet; Capsule; Suspension; Solution
    RouteOral
    Strength1mg/5ml; 1mg; 2mg; 1mg/7.5ml
    Market StatusOver the Counter; Prescription
    CompanyWockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan

    4 of 8  
    Drug NameLoperamide hydrochloride and simethicone
    Drug LabelIMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact...
    Active Ingredientsimethicone; Loperamide hydrochloride
    Dosage FormTablet; Tablet, chewable
    RouteOral
    Strength125mg; 2mg
    Market StatusOver the Counter
    CompanyRanbaxy; Perrigo

    5 of 8  
    Drug NameImodium
    Active IngredientLoperamide hydrochloride
    Dosage FormCapsule
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyMcneil Cons

    6 of 8  
    Drug NameImodium a-d ez chews
    Active IngredientLoperamide hydrochloride
    Dosage FormTablet, chewable
    RouteOral
    Strength2mg
    Market StatusOver the Counter
    CompanyMcneil

    7 of 8  
    Drug NameLoperamide hydrochloride
    PubMed HealthLoperamide (By mouth)
    Drug ClassesAntidiarrheal, Gastrointestinal Agent
    Drug LabelLoperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s...
    Active IngredientLoperamide hydrochloride
    Dosage FormTablet; Capsule; Suspension; Solution
    RouteOral
    Strength1mg/5ml; 1mg; 2mg; 1mg/7.5ml
    Market StatusOver the Counter; Prescription
    CompanyWockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan

    8 of 8  
    Drug NameLoperamide hydrochloride and simethicone
    Drug LabelIMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact...
    Active Ingredientsimethicone; Loperamide hydrochloride
    Dosage FormTablet; Tablet, chewable
    RouteOral
    Strength125mg; 2mg
    Market StatusOver the Counter
    CompanyRanbaxy; Perrigo

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antidiarrheals

    Miscellaneous agents found useful in the symptomatic treatment of diarrhea. They have no effect on the agent(s) that cause diarrhea, but merely alleviate the condition. (See all compounds classified as Antidiarrheals.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Agonists [MoA]; Opioid Agonist [EPC]

    API Reference Price

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MALPENSA","customer":"ADCOCK INGRAM LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1150","totalValueFC":"12249.8","currency":"USD","unitRateINR":"101683.7","date":"29-Sep-2023","totalValueINR":"1016836.9","totalValueInUsd":"12249.8","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"8065397","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEIN BUILDING, PIETHEINKADE 107 1019 GM AMSTERDAMSDNF NETHERLANDS","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699468200,"product":"LOPERAMIDE HYDROCHLORIDE","address":"ASURVEY NO.225, SAMPANBOLE VILLAGE","city":"","supplier":"TEVA API BV","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ALPHAMED FORMULATIONS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"1150","totalValueFC":"12783.6","currency":"USD","unitRateINR":"96772.5","date":"09-Nov-2023","totalValueINR":"1064497.5","totalValueInUsd":"12783.6","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"8687970","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE107, 1019 GM AMSTERDAMTHE NETHERLANDS NL","customerAddress":"ASURVEY NO.225, SAMPANBOLE VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710959400,"product":"7035389 LOPERAMIDE HCL","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"TEVA API BV","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"IPCA LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1200","totalValueFC":"60516.1","currency":"USD","unitRateINR":"100500","date":"21-Mar-2024","totalValueINR":"5025000","totalValueInUsd":"60516.1","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"2685129","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 107 1019 GM AMSTERDAM Amsterdam, , Netherlands Netherlands","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713810600,"product":"LOPERAMIDE HYDROCHLORIDE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"OLON SPA","supplierCountry":"ITALY","foreign_port":"MILAN - 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MALPENSA","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 107,1019 GM AMSTERDAM SDNF NETHERLANDS","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731004200,"product":"LOPERAMIDE HYDROCHLORIDE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"OLON SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CIPLA LIMITED","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"805","totalValueFC":"12191.2","currency":"USD","unitRateINR":"68586","date":"08-Nov-2024","totalValueINR":"1028790","totalValueInUsd":"12191.2","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"6557762","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SEDE LEGALE STRADA RIVOLTANA KM 6\/7 RODANO (MI) ITALY","customerAddress":"MUMBAI CENTRAL,"}]
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    23-Apr-2025
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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 19860

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    ABOUT THIS PAGE

    Looking for 34552-83-5 / Loperamide Hydrochloride API manufacturers, exporters & distributors?

    Loperamide Hydrochloride manufacturers, exporters & distributors 1

    30

    PharmaCompass offers a list of Loperamide Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Loperamide Hydrochloride manufacturer or Loperamide Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loperamide Hydrochloride manufacturer or Loperamide Hydrochloride supplier.

    PharmaCompass also assists you with knowing the Loperamide Hydrochloride API Price utilized in the formulation of products. Loperamide Hydrochloride API Price is not always fixed or binding as the Loperamide Hydrochloride Price is obtained through a variety of data sources. The Loperamide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Loperamide Hydrochloride

    Synonyms

    34552-83-5, Loperamide hcl, Imodium, Suprasec, Loperamide (hydrochloride), Fortasec

    Cas Number

    34552-83-5

    Unique Ingredient Identifier (UNII)

    77TI35393C

    About Loperamide Hydrochloride

    One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.

    Loperamide Manufacturers

    A Loperamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loperamide, including repackagers and relabelers. The FDA regulates Loperamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loperamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Loperamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Loperamide Suppliers

    A Loperamide supplier is an individual or a company that provides Loperamide active pharmaceutical ingredient (API) or Loperamide finished formulations upon request. The Loperamide suppliers may include Loperamide API manufacturers, exporters, distributors and traders.

    click here to find a list of Loperamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Loperamide USDMF

    A Loperamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Loperamide active pharmaceutical ingredient (API) in detail. Different forms of Loperamide DMFs exist exist since differing nations have different regulations, such as Loperamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Loperamide DMF submitted to regulatory agencies in the US is known as a USDMF. Loperamide USDMF includes data on Loperamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loperamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Loperamide suppliers with USDMF on PharmaCompass.

    Loperamide JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Loperamide Drug Master File in Japan (Loperamide JDMF) empowers Loperamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Loperamide JDMF during the approval evaluation for pharmaceutical products. At the time of Loperamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Loperamide suppliers with JDMF on PharmaCompass.

    Loperamide KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Loperamide Drug Master File in Korea (Loperamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loperamide. The MFDS reviews the Loperamide KDMF as part of the drug registration process and uses the information provided in the Loperamide KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Loperamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Loperamide API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Loperamide suppliers with KDMF on PharmaCompass.

    Loperamide CEP

    A Loperamide CEP of the European Pharmacopoeia monograph is often referred to as a Loperamide Certificate of Suitability (COS). The purpose of a Loperamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Loperamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Loperamide to their clients by showing that a Loperamide CEP has been issued for it. The manufacturer submits a Loperamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Loperamide CEP holder for the record. Additionally, the data presented in the Loperamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Loperamide DMF.

    A Loperamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Loperamide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Loperamide suppliers with CEP (COS) on PharmaCompass.

    Loperamide WC

    A Loperamide written confirmation (Loperamide WC) is an official document issued by a regulatory agency to a Loperamide manufacturer, verifying that the manufacturing facility of a Loperamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Loperamide APIs or Loperamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Loperamide WC (written confirmation) as part of the regulatory process.

    click here to find a list of Loperamide suppliers with Written Confirmation (WC) on PharmaCompass.

    Loperamide NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Loperamide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Loperamide API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Loperamide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Loperamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Loperamide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Loperamide suppliers with NDC on PharmaCompass.

    Loperamide GMP

    Loperamide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Loperamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Loperamide GMP manufacturer or Loperamide GMP API supplier for your needs.

    Loperamide CoA

    A Loperamide CoA (Certificate of Analysis) is a formal document that attests to Loperamide's compliance with Loperamide specifications and serves as a tool for batch-level quality control.

    Loperamide CoA mostly includes findings from lab analyses of a specific batch. For each Loperamide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Loperamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Loperamide EP), Loperamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Loperamide USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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